Promus PREMIER™ H7493952832220Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729844945), received between Dec 15, 2016 and Oct 3, 2018 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 3, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT CIRCUMFLEX (LCX) ARTERY. AFTER A BSC STENT WAS DEPLOYED IN THE PROXIMAL LCX, A 2.25X32MM PROMUS PREMIER STENT WAS ADVANCED BUT FAILED TO CROSS THE DISTAL LESION. DURING REMOVAL, THE STENT GOT CAUGHT ON THE DISTAL EDGE OF THE PROXIMAL STENT AND DISLODGED. SUBSEQUENTLY, THE DISLODGED STENT WAS DEPLOYED USING A SEMI COMPLIANT AND NON COMPLIANT BALLOONS AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7930666 ↗
• InjurySep 6, 2018Difficult to Remove; Device-Device Incompatibility; Device Dislodged or Dislocated; Difficult to Remove; Device-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED AND REMOVAL DIFFICULTIES WERE ENCOUNTERED. A 2.25X32 MM PROMUS PREMIER STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT EMBOLIZED FROM THE OBTUSE MARGINAL IN THE DUEL OSTIUM LEFT SYSTEM. UPON REMOVAL OF THE ENTIRE SYSTEM, THE STENT INADVERTENTLY SNAGGED THE OVER-HANG OF A 3.5 PROMUS PREMIER STENT IN THE LEFT MAIN ARTERY. THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICES BUT BOTH STENTS COULD NOT BE PULLED INTO THE SHEATH AND REMAINED IN THE FEMORAL ARTERY. A CONTRALATERAL APPROACH WAS PERFORMED WITH A NON-BSC SELF-EXPANDING STENT THAT WAS PLACED TO COVER BOTH STENTS IN THE FEMORAL ARTERY. THE SECTION WAS POST-DILATED AND THE PROCEDURE WAS COMPLETED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7851291 ↗
• MalfunctionAug 3, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.25X32MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED INTO THE GUIDE CATHETER; HOWEVER, IT WAS NOTED THAT THE STENT CAME OFF OF THE BALLOON AND WAS STICKING AS IT ENTERED THE GUIDE CATHETER. THE DEVICE WAS RETRIEVED BUT IT LOOSEN ON THE BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7747147 ↗
• MalfunctionApr 11, 2018Device Damaged Prior to Use; Device Dislodged or Dislocated; Device Damaged Prior to Use; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. DURING PREPARATION OF A 2.25X32MM PROMUS PREMIER¿ STENT, IT WAS NOTED THAT THE STENT CAME OFF ON THE BACK TABLE AFTER THE STENT PROTECTIVE COVER WAS REMOVED. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7421464 ↗
• MalfunctionSep 15, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.25X32MM PROMUS PREMIER DRUG-ELUTING STENT WAS SELECTED FOR USE TO TREAT THE LESION. HOWEVER, DURING PREPARATION, IT WAS NOTICED THAT SOME OF THE STENT STRUTS LOOKED BENT ON THE STENT DELIVERY SYSTEM (SDS). THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6868222 ↗
• MalfunctionFeb 22, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.25X32MM PROMUS PREMIER¿ STENT WAS ADVANCED TO TREAT THE TARGET LESION. HOWEVER, DURING PROCEDURE, THE STENT WOULD NOT ADVANCE THROUGH THE GUIDE AND WAS BENT IN THE PROCESS. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS OKAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6349530 ↗
• MalfunctionDec 15, 2016Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 2.25X32MM PROMUS PREMIER¿ A DRUG-ELUTING STENT WAS SELECTED TO TREAT THE LESION. HOWEVER, THE STENT WAS OFF THE BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6176962 ↗